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Recruiting NCT07294651

Percutaneous Electrolysis of the Upper Trapezius in Chronic Neck Pain

No phase Interventional Myofascial Pain of Upper Trapezius Muscle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-Intensity Percutaneous Electrolysis of the Upper Trapezius, High-Intensity Percutaneous Electrolysis of the Upper Trapezius, Upper Trapezius Stretching Exercise Program.
Who it may be relevant to
Registry conditions: Myofascial Pain of Upper Trapezius Muscle. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of Different Percutaneous Electrolysis Treatment Protocols Targeting the Upper Trapezius Muscle in Chronic Neck Pain: A Randomized Controlled Trial

Overview

In the planned study, we aim to investigate the effectiveness of percutaneous electrolysis treatment applied to myofascial trigger points in the upper trapezius muscle in patients with chronic neck pain. Two different protocols, a low-intensity (0.5 mA × 90 s) and a high-intensity (3 mA × 3 s × 3 repetitions), will be compared in the study. Patients participating in the research will be randomized into 2 groups using a computer program. Stretching exercises targeting the upper trapezius muscle will be given to both groups as a home exercise program. In both groups, the percutaneous electrolysis treatment protocol will be performed on the active myofascial trigger points in the upper trapezius muscle on the 1st, 8th, and 14th days of treatment, using 0.3-millimeter acupuncture needles and an EPTE® percutaneous electrolysis device (Ionclinics \& A. Deionic SL, Valencia, Spain). The low-intensity (0.5 milliampere × 90 s) treatment protocol will be applied to Group 1, and the high-intensity (3 milliampere × 3 s × 3 repetitions) treatment protocol will be applied to Group 2. In the study, two different protocols, low-intensity (0.5 mA × 90 s) and high-intensity (3 mA × 3 s × 3 repetitions), will be compared. In this way, it is aimed both to obtain information about optimal dosing and to contribute to the literature for a frequently involved muscle such as the upper trapezius.

Interventions

  • Device Low-Intensity Percutaneous Electrolysis of the Upper Trapezius
    Ultrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device. A low-intensity protocol is used (0.5 mA for 90 seconds per session) on days 1, 8, and 14.
  • Device High-Intensity Percutaneous Electrolysis of the Upper Trapezius
    Ultrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device. A high-intensity protocol is used (3 mA for 3 seconds, repeated 3 times per session) on days 1, 8, and 14.
  • Other Upper Trapezius Stretching Exercise Program
    Home-based stretching exercise program targeting the upper trapezius muscle throughout the treatment period in both groups.

Primary outcome measures

  • Change in Pain Intensity (VAS) [Time frame: Baseline (before treatment), immediately after completion of the 3rd treatment session (approximately 2 weeks), and 3 months after treatment initiation.]
Secondary outcome measures (2)
  • Change in Pressure Pain Threshold (Algometry) [Time frame: Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.]
  • Change in Functional Disability (Modified Neck Disability Index) [Time frame: Baseline (prior to the first treatment session), immediately after completion of treatment (after the third session, approximately 2 weeks from baseline), and 3 months after treatment initiation.]

Eligibility criteria

Inclusion criteria

Patients who agree to participate in the study, are between 18 and 70 years of age, have had symptoms for at least 3 months, and have chronic neck pain with active myofascial trigger points in the upper trapezius muscle will be included.

Exclusion criteria

Patients with malignancy, active infection, a history of widespread inflammatory rheumatic disease or fibromyalgia, trauma, skin lesions, infection or open wounds at the myofascial trigger point region, coagulopathy, warfarin use, a history of spinal or shoulder disorders, previous neck or upper extremity surgery, acute illness, muscle diseases, epilepsy, use of sedative medications, needle phobia, previous dry needling treatment for myofascial pain, a cardiac pacemaker, metal implants in the treatment area, conditions that contraindicate physiotherapy such as pregnancy, or metal allergy will not be included in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Sivas Devlet Hastanesi — Sivas

Identifiers

NCT: NCT07294651 · EPTE-MAS-001-S

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗